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SMMT's Q3 Loss Wider Than Expected, Stock Down on Study Amendments
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Key Takeaways
{\"0\":\"Summit Therapeutics reported Q3 loss of 31 cents per share due to a sharp rise in operating expenses.\",\"1\":\"SMMT plans to file for FDA approval of ivonescimab plus chemotherapy in NSCLC by year-end.\",\"2\":\"The stock fell, likely due to the major amendment in the HARMONi-3 study.\"}
Summit Therapeutics (SMMT - Free Report) reported third-quarter 2025 loss per share of 31 cents, much wider than the Zacks Consensus Estimate of a loss of 14 cents. In the year-ago period, the company had incurred a loss of 8 cents.
The reported loss included stock-based compensation expenses. Excluding these expenses, the adjusted loss per share was 13 cents, wider than the year-ago adjusted loss of 5 cents.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in the quarter.
More on SMMT’s Earnings
Adjusted research and development expenses totaled $90.5 million, up 184% year over year. This was mainly due to an increase in clinical costs to support the company’s pipeline development.
Adjusted general and administrative expenses surged 82% year over year to $12.9 million. This uptick was due to higher costs related to building the infrastructure to support the development of ivonescimab.
As of Sept. 30, 2025, Summit had cash, cash equivalents and short-term investments worth $238.6 million compared with $297.9 million as of June 30, 2025.
SMMT’s Pipeline Updates
Summit has only one pipeline drug in its portfolio, ivonescimab, a first-in-class bispecific antibody that targets two proteins, namely PD-1 and VEGF. The company is currently conducting three late-stage studies, HARMONi, HARMONi-3 and HARMONi-7, evaluating ivonescimab in separate settings for non-small cell lung cancer (NSCLC). The drug is being developed in collaboration with China-based Akeso.
Alongside its Q3 results, Summit announced plans to submit a regulatory filing to the FDA by year-end, seeking approval for ivonescimab plus chemotherapy as a treatment for adults with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed following an EGFR-TKI therapy. The filing will be supported by data from the HARMONi study, which met one of its two primary endpoints — progression-free survival. Although the study did not meet the overall survival (OS) endpoint, which the FDA had previously identified as a key requirement for filing, the results showed a favorable trend toward OS. Summit maintains that the ivonescimab-based regimen provides a meaningful clinical benefit over the current standard of care.
In a separate press release, SMMT reported additional data from the Akeso-sponsored phase III HARMONi-6 study, which evaluated ivonescimab plus chemotherapy against BeOne Medicines’ (ONC - Free Report) PD-1 inhibitor Tevimbra plus chemotherapy in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression. Data from the study showed that treatment with ivonescimab reduced the risk of disease progression or death by 40% versus the BeOne Medicines drug.
Additionally, Summit Therapeutics announced major protocol amendments to the HARMONi-3 study, which compares ivonescimab plus chemotherapy against Merck’s (MRK - Free Report) blockbuster drug Keytruda plus chemotherapy in patients with first-line metastatic NSCLC. Under the revised design, the company will now conduct separate analyses for patients with squamous NSCLC and non-squamous NSCLC.
Shares of Summit were down nearly 5% on Monday, likely reflecting investor concern over the amended HARMONi-3 protocol. While the positive HARMONi-6 data reaffirmed ivonescimab’s potential in squamous NSCLC, the unexpected expansion and subgroup separation of HARMONi-3 — coming roughly two years after the study’s initiation in 2023 — have been interpreted by investors as signs of lower confidence in the drug’s effect size and a possible delay in timelines for the study results. Some investors were also not impressed with the higher-than-expected loss reported during the quarter.
Year to date, the stock has risen over 12% compared with the industry’s increase of 9%.
Image Source: Zacks Investment Research
Summit is also expanding the development of ivonescimab beyond NSCLC. Last week, the company announced plans to start the phase III HARMONi-GI3 study, which will evaluate the drug in combination with chemotherapy against bevacizumab plus chemotherapy in patients with first-line unresectable metastatic colorectal cancer (CRC). Enrolment in this study is expected to start before year-end.
Like HARMONi-GI3, Summit plans to start more late-stage studies on ivonescimab. It intends to provide more details of the same in the first quarter of 2026.
Image: Bigstock
SMMT's Q3 Loss Wider Than Expected, Stock Down on Study Amendments
Key Takeaways
Summit Therapeutics (SMMT - Free Report) reported third-quarter 2025 loss per share of 31 cents, much wider than the Zacks Consensus Estimate of a loss of 14 cents. In the year-ago period, the company had incurred a loss of 8 cents.
The reported loss included stock-based compensation expenses. Excluding these expenses, the adjusted loss per share was 13 cents, wider than the year-ago adjusted loss of 5 cents.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in the quarter.
More on SMMT’s Earnings
Adjusted research and development expenses totaled $90.5 million, up 184% year over year. This was mainly due to an increase in clinical costs to support the company’s pipeline development.
Adjusted general and administrative expenses surged 82% year over year to $12.9 million. This uptick was due to higher costs related to building the infrastructure to support the development of ivonescimab.
As of Sept. 30, 2025, Summit had cash, cash equivalents and short-term investments worth $238.6 million compared with $297.9 million as of June 30, 2025.
SMMT’s Pipeline Updates
Summit has only one pipeline drug in its portfolio, ivonescimab, a first-in-class bispecific antibody that targets two proteins, namely PD-1 and VEGF. The company is currently conducting three late-stage studies, HARMONi, HARMONi-3 and HARMONi-7, evaluating ivonescimab in separate settings for non-small cell lung cancer (NSCLC). The drug is being developed in collaboration with China-based Akeso.
Alongside its Q3 results, Summit announced plans to submit a regulatory filing to the FDA by year-end, seeking approval for ivonescimab plus chemotherapy as a treatment for adults with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed following an EGFR-TKI therapy. The filing will be supported by data from the HARMONi study, which met one of its two primary endpoints — progression-free survival. Although the study did not meet the overall survival (OS) endpoint, which the FDA had previously identified as a key requirement for filing, the results showed a favorable trend toward OS. Summit maintains that the ivonescimab-based regimen provides a meaningful clinical benefit over the current standard of care.
In a separate press release, SMMT reported additional data from the Akeso-sponsored phase III HARMONi-6 study, which evaluated ivonescimab plus chemotherapy against BeOne Medicines’ (ONC - Free Report) PD-1 inhibitor Tevimbra plus chemotherapy in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression. Data from the study showed that treatment with ivonescimab reduced the risk of disease progression or death by 40% versus the BeOne Medicines drug.
Additionally, Summit Therapeutics announced major protocol amendments to the HARMONi-3 study, which compares ivonescimab plus chemotherapy against Merck’s (MRK - Free Report) blockbuster drug Keytruda plus chemotherapy in patients with first-line metastatic NSCLC. Under the revised design, the company will now conduct separate analyses for patients with squamous NSCLC and non-squamous NSCLC.
Shares of Summit were down nearly 5% on Monday, likely reflecting investor concern over the amended HARMONi-3 protocol. While the positive HARMONi-6 data reaffirmed ivonescimab’s potential in squamous NSCLC, the unexpected expansion and subgroup separation of HARMONi-3 — coming roughly two years after the study’s initiation in 2023 — have been interpreted by investors as signs of lower confidence in the drug’s effect size and a possible delay in timelines for the study results. Some investors were also not impressed with the higher-than-expected loss reported during the quarter.
Year to date, the stock has risen over 12% compared with the industry’s increase of 9%.
Image Source: Zacks Investment Research
Summit is also expanding the development of ivonescimab beyond NSCLC. Last week, the company announced plans to start the phase III HARMONi-GI3 study, which will evaluate the drug in combination with chemotherapy against bevacizumab plus chemotherapy in patients with first-line unresectable metastatic colorectal cancer (CRC). Enrolment in this study is expected to start before year-end.
Like HARMONi-GI3, Summit plans to start more late-stage studies on ivonescimab. It intends to provide more details of the same in the first quarter of 2026.
Summit Therapeutics PLC Price
Summit Therapeutics PLC price | Summit Therapeutics PLC Quote
SMMT’s Zacks Rank
Summit currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.